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Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

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ClinicalTrials.gov Identifier: NCT00518453
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

Condition or disease Intervention/treatment Phase
Influenza Biological: Surface antigen inactivated influenza vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
Study Start Date : July 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1: Fluvirin Biological: Surface antigen inactivated influenza vaccine
1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition



Primary Outcome Measures :
  1. evaluate the antibody response to each influenza vaccine antigen [ Time Frame: 21 days post-immunization ]

Secondary Outcome Measures :
  1. Safety and tolerability of the study vaccine in the study population [ Time Frame: Throughout the study ]


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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria:

  • Any serious disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518453


Locations
United Kingdom
The Health Centre
Suffolk, United Kingdom
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines

Additional Information:
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00518453     History of Changes
Other Study ID Numbers: V78P5S
2007-002063-27
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Vaccines ):
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs